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Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1

Primary Purpose

Alcohol-Related Disorders, Alcoholism, Cocaine-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Disulfiram
Placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol-Related Disorders focused on measuring cocaine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Meets DSM-IV criteria for both alcohol and cocaine dependence, as determined by the Structured Clinical Interview(SCID-IV) Successful completion of alcohol detoxification (i.e., 3 consecutive days of abstinence from alcohol) Use of at least $100 worth of cocaine in the 30 days prior to enrollment In the past 30 days, Subject used no less than $100 worth of cocaine and drank a minimum of 12 standard alcohol drinks/week (on average), having at least four days in 30 where at least four or more drinks were ingested, as determined by the Timeline Followback (TLFB) - adapted to collect daily cocaine use; Able to commute to the treatment research center Speaks, understands, and writes English Understands and signs the informed consent. Exclusion Criteria: Abstinence from alcohol or cocaine for more than 30 days before signing consent form Current DSM-IV diagnosis of any psychoactive substance dependence other than Alcohol, Cocaine or Nicotine dependence, as determined by the SCID; Evidence of opiate use in the past 30 days as assessed by self-report and intake urine drug screen; History of unstable or serious medical illness, including need for opioid analgesics; Concomitant treatment with phenytoin or from same drug class, lithium, serotonin selective reuptake inhibitors, tricyclic antidepressants, MAOI's or narcotics; 6) Use of any investigational medication within the past 30 days; Severe physical or medical illness such as AIDS, active hepatitis or significant hepatocellular injury as evidenced by elevated bilirubin levels; Severe psychiatric symptoms, e.g., psychosis, suicidal or homicidal ideation or mania; Female patients who are pregnant, nursing, or not using a reliable method of contraception. Acceptable methods of birth control include: barrier (diaphragm or condom) with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, oral contraceptives.

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Naltrexone

Disulfiram

Naltrexone and Disulfiram

Placebo

Arm Description

Naltrexone

Disulfiram

Naltrexone and Disulfiram

Placebo

Outcomes

Primary Outcome Measures

Amount of alcohol and drug use.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
January 11, 2017
Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00142844
Brief Title
Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1
Official Title
Two Medications, Disulfiram and Naltrexone, in the Treatment of Patients With Both Cocaine and Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Many cocaine dependent individuals are also dependent on alcohol. Such individuals respond poorly to existing treatments and have received little research attention in the past. The purpose of this study is to determine whether the combination of naltrexone and disulfiram is useful in decreasing alcohol use and cravings in people diagnosed with both cocaine and alcohol dependence.
Detailed Description
Many cocaine dependent individuals are also dependent on alcohol. Such individuals respond poorly to existing treatments and have received little research attention in the past. Naltrexone and disulfiram are medications currently approved for treating alcohol dependence. These two medications have different mechanisms of action in the body. In combination they might be effective in treating individuals dually diagnosed with cocaine and alcohol dependence. The purpose of this study is to determine whether the combination of naltrexone and disulfiram is useful in decreasing alcohol cravings in individuals who are dependent on both cocaine and alcohol. Participants in this 5-year, double-blind study will be randomly assigned to receive disulfiram, naltrexone, both, or placebo. Treatment will occur for a 3-month period, after which alcohol, cocaine use, and other biopsychosocial measures will be assessed at Months 6 and 9.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Related Disorders, Alcoholism, Cocaine-Related Disorders
Keywords
cocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naltrexone
Arm Type
Experimental
Arm Description
Naltrexone
Arm Title
Disulfiram
Arm Type
Experimental
Arm Description
Disulfiram
Arm Title
Naltrexone and Disulfiram
Arm Type
Experimental
Arm Description
Naltrexone and Disulfiram
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Type
Drug
Intervention Name(s)
Disulfiram
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Amount of alcohol and drug use.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Meets DSM-IV criteria for both alcohol and cocaine dependence, as determined by the Structured Clinical Interview(SCID-IV) Successful completion of alcohol detoxification (i.e., 3 consecutive days of abstinence from alcohol) Use of at least $100 worth of cocaine in the 30 days prior to enrollment In the past 30 days, Subject used no less than $100 worth of cocaine and drank a minimum of 12 standard alcohol drinks/week (on average), having at least four days in 30 where at least four or more drinks were ingested, as determined by the Timeline Followback (TLFB) - adapted to collect daily cocaine use; Able to commute to the treatment research center Speaks, understands, and writes English Understands and signs the informed consent. Exclusion Criteria: Abstinence from alcohol or cocaine for more than 30 days before signing consent form Current DSM-IV diagnosis of any psychoactive substance dependence other than Alcohol, Cocaine or Nicotine dependence, as determined by the SCID; Evidence of opiate use in the past 30 days as assessed by self-report and intake urine drug screen; History of unstable or serious medical illness, including need for opioid analgesics; Concomitant treatment with phenytoin or from same drug class, lithium, serotonin selective reuptake inhibitors, tricyclic antidepressants, MAOI's or narcotics; 6) Use of any investigational medication within the past 30 days; Severe physical or medical illness such as AIDS, active hepatitis or significant hepatocellular injury as evidenced by elevated bilirubin levels; Severe psychiatric symptoms, e.g., psychosis, suicidal or homicidal ideation or mania; Female patients who are pregnant, nursing, or not using a reliable method of contraception. Acceptable methods of birth control include: barrier (diaphragm or condom) with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, oral contraceptives.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen M Pettinati, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104 6178
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18079068
Citation
Pettinati HM, Kampman KM, Lynch KG, Xie H, Dackis C, Rabinowitz AR, O'Brien CP. A double blind, placebo-controlled trial that combines disulfiram and naltrexone for treating co-occurring cocaine and alcohol dependence. Addict Behav. 2008 May;33(5):651-67. doi: 10.1016/j.addbeh.2007.11.011. Epub 2007 Nov 17.
Results Reference
result
Links:
URL
http://www.med.upenn.edu/csa/
Description
University of Pennsylvania Center for Studies of Addiction

Learn more about this trial

Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1

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